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Completed

NCT Number: NCT04930835

Treatment Outcomes With Full Arch Rehabilitations Retained by Immediate or Conventionally Loaded Implants

This study aims to assess the treatment outcomes (clinical, functional and subjective) of full arch rehabilitations supported by implants with or without an immediate loading protocol. In this randomized clinical trial 20 fully edentulous patients were treated with full arch rehabilitations on dental implants. In half of the sample, the implants were loaded immediately by means of abutments after emplacement of the implant; but in the counterparts these abutments were connected to implants two months after the surgery (conventional protocol), and until that time the dentures were retained by healing abutments. Treatment outcomes were assessed at 2, 6 and 12 months after surgery. Clinical outcomes were quantified on the basis of implant failure rate, marginal bone loss and the peri-implant gingival index. Functional outcomes were calculated according to masticatory performance, estimated by the mixed fraction of a two-coloured chewing gum after 5, 10 and 15 chewing strokes, by the occlusal force recorded by pressure-sensitive sheets and by the bioelectrical muscular activity. The subjective outcomes of the treatment were assessed using both the oral satisfaction scale (visual analogue scale) and the Spanish version of the Oral Health Impact Profile (OHIP-20).

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Key information

Conditions

Edentulous Jaw Anodontia Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Jaw Diseases Jaw, Edentulous Missing Teeth Mouth Diseases Mouth, Edentulous Musculoskeletal Diseases Stomatognathic Diseases Stomatognathic System Abnormalities Tooth Abnormalities Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinica Odontológica de la Universidad de Salamanca

Salamanca, 37007, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • completely edentulous individuals who had lacked teeth for more than 10 years, routine users of conventional complete prostheses.
  • sufficient amount of remaining bone to receive the implants in the region of the mandibular canines (minimum height=15 mm/minimum ridge width= 5mm)
  • no evidence of systemic or psychic pathology that might contraindicate the implant treatment.

Exclusion criteria

  • Those in which oral surgery or cognitive evaluations are contraindicated

Treatment and study plan

Implant supported dentures

Procedure

Placement of dental implants with different loading protocols for supporting full arch dentures.

Primary outcomes

  1. Clinical Performance of Dental implants

    Time frame: One year after treatment

    Implant failure rate

  2. Oral health-related quality of life

    Time frame: One year after treatment

    impact according to the OHIP-20 (Oral Health Impact Profile) instrument. The score range from 0 to 20, being 20 the worst outcome.

  3. Mastication

    Time frame: One year after treatment

    Mixing ability tests

  4. Area of Occlusal Occlusion

    Time frame: One year after treatment

    According to pressure-sensitive colorimetric sheets it is recorded the area in square millimeters

  5. Occlusal Load

    Time frame: One year after treatment

    According to the pressure-sensitive colorimetric sheets , the load in both the anterior and posterior region of the arch are calculated.

Sponsors and collaborators

Lead sponsor

University of Salamanca

Other

Registry information

Official study title

Treatment Outcomes With Full Arch Rehabilitations Supported by Immediate or Conventionally Loaded Implants: A Randomized Clinical Trial

Acronym: ILOD

Important dates

Study start
2018
Primary completion
2018
Study completion
2021
First posted
Jun 18, 2021
Registry last updated
Jun 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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